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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna-reagents, neisseria
510(k) Number K061509
Device Name TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196
Original Applicant
GEN-PROBE, INC.
10210 genetic center dr.
san diego,  CA  92121 4362
Original Contact brian j shea
Regulation Number866.3390
Classification Product Code
LSL  
Date Received06/01/2006
Decision Date 10/04/2006
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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